System and method for validating the crimping of a vial having a stopper and a cap

ABSTRACT

A system and method for validating the crimping of a vial having a stopper and a cap are disclosed. According to one embodiment, the system comprises a crimping cylinder, a controller that validates the crimping of the cap to the vial; and an indicator for indicating whether the crimping was validated. The crimping cylinder comprises a piston; a plurality of crimping jaws interacting with the piston, the crimping jaws moving to a closed position when the piston is moved in a downward direction, and the crimping jaws moving to an open position when the piston is moved in an upward direction; a position indicator; and a position sensor. The position indicator and position sensor indicate a position of the piston.

This application is based on and claims the benefit of U.S. Provisional Patent Application No. 60/950,913, filed Jul. 20, 2007, the disclosure of which is incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention generally relates to the sealing of vials containing radiopharmaceuticals, and, more particularly, to a system and method for validating the crimping of a vial having a stopper and a cap.

2. Description of the Related Art

Medical imaging is used extensively to diagnose and treat patients. A number of modalities are well known, such as Magnetic Resonance Imaging (MRI), Computed Tomography (CT), Positron Emission Tomography (PET), and Single Photon Emission Computed Tomography (SPECT). These modalities provide complementary diagnostic information. For example, PET and SPECT scans illustrate functional aspects of the organ or region being examined and allow metabolic measurements, but delineate the body structure relatively poorly. On the other hand, CT and MRI images provide excellent structural information about the body, but provide little functional information.

PET and SPECT are classified as “nuclear medicine” because they measure an emission of a radioactive tracer that has been injected into a patient. After the radioactive tracer, or radiopharmaceutical, is injected, it is absorbed by the blood or a particular organ of interest. The patient is then moved into the PET or SPECT detector that measures the emission of the radiopharmaceutical and creates an image from the characteristics of the detected emission.

A significant step in conducting a PET or SPECT scan is the step of acquiring the radioactive tracer. Examples of radiopharmaceuticals include FDG (2-[¹⁸F]-fluoro-2-deoxyglucose), other ¹⁸F-based fluorinated tracers, ¹³N ammonia, ¹¹C based tracers, ¹⁵O gas, and ¹⁵O water, and others.

The half lives of these radiopharmaceuticals range from two minutes to two hours. Thus, the injection into the patient and the imaging must take place within a very short time period after production of the radiopharmaceutical. Hospitals without the facilities to manufacture radiopharmaceuticals must order them to be delivered by ground or air transport from nearby manufacturing facilities, which can be very expensive.

In response to the growing practice of using nuclear medicine imaging, such as PET, many hospitals have built their own radiopharmaceutical manufacturing facilities. Alternatively, transportable manufacturing facilities for radioactive materials, such as FASTLab™, available from G.E. Healthcare, may be used. An example of a transportable manufacturing facility described in U.S. Patent Publ. No. 2004/0086437, the disclosure of which is incorporated by reference in its entirety.

Regardless of source, after radiopharmaceuticals are dispensed into vials, they may be sealed by using a stopper, and then an aluminum cap may be crimped over the stopper to secure the stopper in place. It is important to ensure that the aluminum cap is safely crimped over the stopper so that the contents of the vial will not leak. This is typically accomplished by visual inspection.

SUMMARY OF THE INVENTION

A system and method for validating the crimping of a vial having a stopper and a cap are disclosed. According to one embodiment, the system comprises a crimping cylinder, a controller that validates the crimping of the cap to the vial; and an indicator for indicating whether the crimping was validated. The crimping cylinder comprises a piston; a plurality of crimping jaws interacting with the piston, the crimping jaws moving to a closed position when the piston is moved in a downward direction, and the crimping jaws moving to an open position when the piston is moved in an upward position; a position indicator; and a position sensor. The position indicator and position sensor indicate a position of the piston.

The crimping cylinder may be a pneumatic cylinder. The system may further comprise at least one source of compressed air. The position indicator may comprise a magnet, and the position sensor may comprise a magnetic position sensor. The controller may validate the crimping of the cap to the vial based on the position of the piston. Responsive to a faulty crimping of the cap to the vial, the controller may determine a specific crimping fault. The specific faults may include the cap being tilted, no stopper in place, the cap is not crimped, and the cap being overly-crimped.

The indicator may comprise a display and/or a speaker.

The method for validating the crimping of a vial having a stopper and a cap includes the steps of (1) positioning a vial, stopper and cap in a crimping cylinder, the crimping cylinder having a piston and a plurality of crimping jaws interacting with the cylinder; (2) moving the piston in a downward direction, the movement causing the crimping jaws to move to a closed position; (3) moving the piston further in a downward direction, the movement causing the crimping jaws to crimp the cap along a neck of the vial; and (4) validating the crimping based on a position of the piston in the crimping device.

The position of the piston may be determined based on a position of a position indicator relative to a position sensor. The position indicator may comprise a magnet, and the position sensor may comprise a magnetic position sensor.

The method may further include the step of determining a specific crimping fault responsive to a faulty crimping of the cap to the vial. The specific faults may include the cap being tilted, no stopper in place, the cap is not crimped, and the cap being overly-crimped.

The method may further include the step of indicating whether the crimping was validated.

The piston may be moved with compressed air.

It is a technical advantage of the present invention that a system and method for validating the crimping of a vial having a stopper and a cap are disclosed. It is another technical advantage of the present invention that a pneumatic cylinder may be used. It is yet another technical advantage of the present invention that the system may determine a specific crimping fault.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present invention, the objects and advantages thereof, reference is now made to the following descriptions taken in connection with the accompanying drawings in which:

FIG. 1 is a schematic of a system for in-process crimping validation according to one embodiment of the present invention.

FIG. 2 is a schematic of the system for in-process crimping validation of FIG. 1 in a second position.

FIG. 3 is a schematic of the system for in-process crimping validation of FIG. 1 in a third position.

FIG. 4 is a flowchart depicting a method for in-process crimping validation according to one embodiment of the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Preferred embodiments and their advantages may be understood by referring to FIGS. 1-4, wherein like reference numerals refer to like elements.

Disclosed herein are a system and method for in-process crimping validation that provides an efficient and effective way to verify the propriety of a mechanical crimp.

Referring to FIGS. 1-3, a system for in-process crimping validation according to one embodiment of the present invention includes a crimping cylinder 110, such as a pneumatic cylinder, compressed air sources 120 and 125, vial 105, stopper 130, and cap 135.

In one embodiment, vial 105 may be a 15R-c1-1 vial as defined in the standard ISO 8362-1:2003. Stopper 130 may be a 20-A stopper (or closures) as defined in standard ISO 8362-2:1998. Cap 135 may be a B-20 cap as defined in ISO 8362-3:2001.

In one embodiment, stopper 130 may be made of a material, such as an inert rubber, Teflon®-coated rubber, Teflon®, etc. rubber. In one embodiment, cap 135 may be made of aluminum.

According to one embodiment of the invention, compressed air sources 120 and 125 may be the same air source. According to another embodiment, compressed air sources 120 and 125 may be the different air sources.

According to one embodiment, pneumatic cylinder 110 includes crimping jaws 140, connecting link 150, piston 160, position indicator 170, and position sensor 180. In one embodiment, pneumatic cylinder 110 may be a pneumatic cylinder having a 10 mm stroke, available from SMC Corporation of America, Indianapolis, Ind. In one embodiment, crimping jaws 140 and connecting link 140 may be from a commercial manual crimping tool.

Crimping jaws 140 are provided to close and crimp cap 135. In one embodiment, crimping jaws 140 may be shaped at an end to conform to the top of vial 105, including a lip that surrounds the mouth of vial 105. Crimping jaws 140 may be pivotably mounted to move between an open position, illustrated in FIG. 1, and a closed position, illustrated in FIGS. 2 and 3.

Piston 160, connecting link 150, and position indicator 170 are provided in crimping cylinder 110. The position of these elements is controlled by air from air sources 120 and 125. When air is provided from air source 120, these elements move downward toward vial 105. When air is provided from air source 125, these elements move upward away from vial 105.

The movement of connecting link 150 in a downward direction causes crimping jaws 140 to move from the open position (FIG. 1) to the closed position (FIGS. 2 and 3). Conversely, movement of connecting link in an upward direction causes crimping jaws 140 to move from the closed position to the open position. As crimping jaws 140 move into the closed position, their ends interact with the peripheries of cap 135 and stopper 130 around vial 105.

Position indicator 170 is provided so that the position of piston 160, connecting link 150, and crimping jaws 140, can be determined. In one embodiment, position indicator 170 is a magnet, and position sensor 180 may be a magnetic position sensor.

Controller 190 controls the application of air from compressed air sources 120 and 125, and also monitors the position of position indicator 170 relative to position sensor 180. In one embodiment, controller 190 may control valves (not shown) that control the flow of air from air sources 120 and 125. In one embodiment, controller 190 may be a PLC, such as B&R series 2003, manufactured by B&R Industrieelektronik, Austria.

Indicator 195 may be provided to inform the user whether the crimping of the cap to the vial was validated. If the crimping was not validated, indicator 195 may indicate the specific crimping fault (e.g., whether the cap is tilted, if there is no rubber stopper in place, if the cap is not crimped, or if the cap is overly-crimped) to the user.

In one embodiment, indicator 195 may be a display. In one embodiment, indicator 195 may include a display, such as a light-emitting diode (LED), a plurality of LEDs, a LED display, a liquid crystal display (LCD), a plasma screen, etc. In another embodiment, indicator 195 may include a speaker that uses audio, such as tones, generated or recorded voice cues, etc. to inform the user whether the crimping was validated and/or the specific crimping faults.

In another embodiment, indicator 195 may be part of a graphical user interface for a larger system.

Referring to FIG. 4, a method of in-process crimping validation according to one embodiment of the invention is provided. Although this method will be described in the context of the system of FIGS. 1-3, it should be recognized that the method is not limited to use with such a system.

In step 410, stopper 130 is inserted into the mouth of vial 105, and then covered with cap 135. An example of this step is shown in FIG. 1.

In step 420, connecting link 150 is forced in the downward direction (i.e., toward vial 105) by introducing compressed air from compressed air source 120 into crimping cylinder 110. As a result of this movement, the neck of vial 105, stopper 130, and cap 135 are aligned, as shown in FIG. 2.

In another embodiment, a predetermined amount of compressed air may be provided in order to move connecting link 150 to a predetermined position. The actual position of connecting link 150 is monitored by the position of position indicator 170 relative to position sensor 180.

In one embodiment, the position of position indicator 170 relative to position sensor 180 is monitored in order to determine when to stop movement of connecting link 150.

In step 430, cap 135 is deformed to secure stopper 130 in position. In one embodiment, compressed air is introduced further from compressed air source 120 into crimping cylinder 110. This results in connecting link 150, piston 160, position indicator 170, and crimping jaws 140 moving downward (i.e., further towards vial 105). As a result, the ends of crimping jaws 140 cause cap 135 to conform to the lower part of the neck of vial 105. The result of this step is shown in FIG. 3.

In another embodiment, a predetermined amount of compressed air may be provided in order to move connecting link 150 to a predetermined position. The actual position of connecting link 150 is monitored by the position of position indicator 170 relative to position sensor 180.

In one embodiment, the position of position indicator 170 relative to position sensor 180 is monitored in order to determine when to stop movement of connecting link 150.

In step 440, it is determined whether the cap has been properly secured. In order to do this, the position of position indicator 170 relative to position sensor 180 is determined. If cap 135 is tilted, cap 135 is not deformed, or the deformation of cap 135 exceeds a standard amount of deformation, the position of position indicator 170 will not be located at a predetermined position relative to position sensor 180 after step 430.

If the position of position indicator 170 is within a tolerance of a predetermined position, thereby indicating a proper crimp and a safe seal, in step 450, the operator is informed that the crimp is proper. If the position of position indicator 170 is not within a tolerance of a predetermined position, thereby indicating an erroneous crimp and an unsafe seal, in step 460, the operator is informed that the crimp is not proper.

In one embodiment, the position of position indicator 170 relative to position sensor 180 may be used to indicate the specific fault with the crimping. For example, the position of position indicator 170 may be used to determine whether the cap is tilted, if there is no stopper in place, if the cap is not crimped, or if the cap is overly-crimped. In one embodiment, the system may be calibrated based on the final position of position indicator 170 when a proper crimp provided. After calibration, a final position of position indicator 170 that is short of the proper crimp reference will indicate an improper crimp. A final position of position indicator 170 that is close to, but short of the proper crimp reference, will indicate a tilted cap. A final position of position indicator 170 that is beyond the proper crimp reference will indicate an overly-crimped cap. A final position of position indicator 170 that is well-beyond the proper crimp reference will indicate a lack of stopper. Other final positions of position indicator 170 may also be used.

Other embodiments, uses, and advantages of the present invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. The specification and examples should be considered exemplary only. 

1. A system for validating the crimping of a vial having a stopper and a cap, comprising: a crimping cylinder, comprising: a piston; a plurality of crimping jaws interacting with the piston, the crimping jaws moving to a closed position when the piston is moved in a downward direction, and the crimping jaws moving to an open position when the piston is moved in an upward position; a position indicator; and a position sensor, wherein the position indicator and position sensor indicate a position of the piston; a controller that validates the crimping of the cap to the vial; and an indicator for indicating whether the crimping was validated.
 2. The system of claim 1, wherein the crimping cylinder is a pneumatic cylinder and the system further comprises: at least one source of compressed air pneumatically coupled to the crimping cylinder.
 3. The system of claim 1, wherein the position indicator comprises a magnet, and the position sensor comprises a magnetic position sensor.
 4. The system of claim 1, wherein the controller validates the crimping of the cap to the vial based on the position of the piston.
 5. The system of claim 4, wherein, responsive to a faulty crimping of the cap to the vial, the controller determines a specific crimping fault.
 6. The system of claim 5, wherein the specific crimping fault is selected from the group consisting of the cap being tilted, no stopper is in place, the cap is not crimped, and the cap is overly-crimped.
 7. The system of claim 1, wherein the indicator comprises at least one of a display and a speaker.
 8. A method for validating the crimping of a vial having a stopper and a cap, comprising: positioning a vial, a stopper and a cap in a crimping cylinder, the crimping cylinder having a piston and a plurality of crimping jaws interacting with the piston; moving the piston in a downward direction, the movement causing the crimping jaws to move to a closed position; moving the piston further in a downward direction, the further movement causing the crimping jaws to crimp the cap along a neck of the vial; and validating the crimping based on a position of the piston in the crimping cylinder.
 9. The method of claim 8, wherein the position of the piston is determined based on a position of a position indicator relative to a position sensor.
 10. The method of claim 9, wherein the position indicator comprises a magnet, and the position sensor comprises a magnetic position sensor.
 11. The method of claim 8, further comprising determining a specific crimping fault responsive to a faulty crimping of the cap to the vial.
 12. The method of claim 11, wherein the specific crimping fault is selected from the group consisting of the cap being tilted, no stopper is in place, the cap is not crimped, and the cap is overly-crimped.
 13. The method of claim 8, further comprising: indicating whether the crimping was validated.
 14. The method of claim 8, wherein the piston is moved with compressed air.
 15. An apparatus for validating the crimping of a cap to a vial, comprising: a housing; a piston moveable within the housing; at least one crimping jaw coupled to the piston, wherein movement of the piston in a first direction causes the at least one crimping jaw to move to a closed position and movement of the piston in a second direction causes the at least one crimping jaw to move to an open position; a position sensor for sensing the position of the piston; a controller coupled to the position sensor for validating the crimping of the cap to the vial based on the position of the piston; and an indicator for indicating whether the crimping was validated.
 16. The apparatus of claim 15, wherein movement of the piston towards the vial causes the at least one crimping jaw to move to the closed position, and movement of the piston away from the vial causes the at least one crimping jaw to move to the open position.
 17. The apparatus of claim 15, wherein the controller determines a crimping fault of the cap being tilted when the cap is tilted.
 18. The apparatus of claim 15, wherein the controller determines a crimping fault of a lack of a stopper in the vial when no stopper is present.
 19. The apparatus of claim 15, wherein the controller determines a crimping fault of the cap being not crimped when the cap is not crimped.
 20. The apparatus of claim 15, wherein the controller determines a crimping fault of the cap being overly-crimped when the cap is overly crimped. 